Notice Number: NOT-TR-12-003

Key Dates
Release Date: March 6, 2012
Response Date:  April 6, 2012

Issued by
National Center for Advancing Translational Sciences (NCATS)

Purpose

The National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), seeks comments from all key stakeholders in the scientific and public health communities on how it can further strengthen the Clinical and Translational Science Awards (CTSA) program to meet its broad clinical and translational goals. Key stakeholders include all researchers involved in bringing basic science through the translational pipeline to improve health in the community; those public and private partners who fund such research and services; and members of the public who are advocates, clinicians, patients, and community leaders seeking better diagnostics, treatments, preventions, and cures.

Background

The mission of NCATS is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. The CTSA program, which funds a consortium of medical research institutions to improve clinical and translational research, is an essential component in meeting the NCATS mission. 

The CTSA program provides infrastructure to facilitate translational research, to promote the training and career development of translational researchers, and to develop innovative methods and technologies to strengthen translational research (see http://www.ctsacentral.org/). In fiscal year 2011, the National Center for Research Resources invested $460,566,000 in the current CTSA sites, all academic medical institutions that share the common vision of improving human health by transforming the research and training environments for clinical and translational science. 

Prior to establishing NCATS, the NIH Director established a trans-NIH working group to recommend a strategy for ensuring that the CTSA program most effectively facilitates the translation of science into improved human health. The working group recommended that the CTSA program should continue to provide infrastructure to support the full spectrum of translational research and provided a number of steps to build on the existing strengths of the CTSA program (see http://ncats.nih.gov/recommendations.pdf).

Request for Information

NCATS has reconvened this working group to advise on implementing these recommendations and now seeks public comment as well. Specifically, public comment is sought on how NCATS can better structure and position the CTSA program to develop novel designs, methods and research and enrich the translational pipeline.  Possible areas for comments include, but are not limited to:

1. Positioning the CTSAs to overcome one or more of the barriers in moving insights from research into and along the translational pipeline to inform clinical care
2. Fostering the role of the CTSAs in bringing better health to our communities through implementation and delivery research (e.g., innovative new approaches include mobile tools for outcome assessment, social media for community outreach, analytic approaches to assess health practices, and working with public and private sponsors for community outreach)
3. Identifying critical infrastructure investments that are essential to strengthening translational research (e.g., types of consultative services or clinical research facilities, possible sharing across sites)
4. Aligning resource allocation and needs and infrastructure use at individual sites, and nimbly redirecting as needs change
5. Reducing the costs and time needed for implementing large, multi-site clinical studies (e.g., shared elements such as interoperable IT infrastructure, common financial management tools, and common elements of infrastructure support)
6. Improving the protection of human subjects in ways that simultaneously will improve oversight and minimize burden and delays (e.g., central or reciprocal IRB reviews, model consent processes)
7. Encouraging shared investments with public and private funders, both non-profit and for-profit (e.g., shared goal setting and metrics of success, redistribution or timing of risks and benefits)
8. Establishing priorities for shared, consortial activities across the CTSA sites as well as methods to encourage and support the high priority activities
9. Measuring the value added of the CTSA program for science, the translational mission, and the improvement of the Nation’s health

Submitting a Response

To respond to any of the points above or others, please identify the critical issues(s) and recommended approaches.  Responders are free to address any or all of the above items.

All comments must be submitted electronically to:  NCATSCTSAinformation@mail.nih.gov

Responses to this RFI will be accepted through April 6, 2012. Responders will receive an electronic confirmation acknowledging receipt of a response, but will not receive individualized feedback on any suggestions. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the NIH, and/or NCATS.  NCATS does not intend to make any awards based on responses to this RFI or to otherwise pay for the preparation of any information submitted or for the Government's use of such information.

Proprietary, classified, confidential, or sensitive information should not be included in your response. NCATS will not de-identify responses, so please do not include identifiable information if you want to make confidential comments. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Inquiries

Specific questions about this RFI should be directed to:

ATTN: RFI on Enhancing CTSA Program
National Center for Advancing Translational Sciences
6701 Democracy Blvd, Room 9113, MSC 4874
Bethesda, MD 20892-4874
Email: NCATSCTSAinformation@mail.nih.gov

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